Comparison of TAF and TDF in Preventing Mother-to-Child Transmission of HBV in Pregnancies With High Viral Loads

Официальное название

A Multicenter, Prospective, Open-label, Non-inferiority Randomized Controlled Study on the Efficacy of Tenofovir Alafenamide Fumarate vs. Tenofovir Disoproxil Fumarate in Preventing Mother-to-Child Transmission of Hepatitis B Virus in Pregnant Women With High Viral Loads

Обзор

The main objective of this study is to compare the mother-to-infant transmission rates of hepatitis B between pregnant women receiving treatment with tenofovir alafenamide and those receiving treatment with tenofovir disoproxil fumarate, after administering the hepatitis B vaccine and hepatitis B immunoglobulin to their infants at birth. Investigators define the mother-to-infant transmission rate of hepatitis B as the proportion of infants who are HBsAg positive and have serum HBV DNA \>20 IU/mL at 28 weeks of age among all live births in the experimental group. Additionally, this study will also compare the incidence of congenital defects/malformations in infants born to mothers treated with tenofovir alafenamide and tenofovir disoproxil fumarate during the perinatal period to assess drug safety.

Подробное описание

see summary

Вмешательства

• Препарат TAF group
  Pregnant women will start TAF treatment (25 mg tablet taken orally once daily) from 28 weeks of gestation until delivery. After that, they will be randomly assigned to two subgroups among postpartum mothers without treatment indications: one subgroup will stop treatment, while the other subgroup will continue with an additional 12 weeks of TAF treatment. The mothers and their infants will be followed up at 28 weeks postpartum. Infants will receive the hepatitis B vaccine and HBIG within 12 hours
• Препарат TDF group
  The mother will start receiving TDF treatment (300 mg tablet taken orally once daily) at 28 weeks of pregnancy until delivery. After that, mothers without treatment indications will be randomly assigned to two subgroups: one subgroup will stop treatment, while the other subgroup will receive an additional 12 weeks of TDF treatment. Infants will be vaccinated with the hepatitis B vaccine and HBIG within 12 hours after birth, as well as receive booster doses of the hepatitis B vaccine at 4 weeks a

Первичные конечные точки

• The mother-to-child transmission rate of HBV [Срок оценки: 28 weeks]

Вторичные конечные точки (10)

• Congenital defects/malformations in infants [Срок оценки: 28 weeks]
• The percentage of mothers in each group of pregnant women with HBV DNA below 200,000 IU/mL [Срок оценки: 12 weeks]
• The percentage of mothers who experienced HBeAg/HBsAg clearance or seroconversion [Срок оценки: 36 weeks]
• ALT levels during or after TDF/TAF treatment [Срок оценки: 36 weeks]
• Renal function parameters of pregnant women [Срок оценки: 36 weeks]
• Adverse events (including obstetric complications and laboratory abnormalities) [Срок оценки: 36 weeks]
• Proportion of two groups that discontinued treatment due to adverse events [Срок оценки: 36 weeks]
• Health-related quality of life (HRQoL) indicators of pregnant women [Срок оценки: 36 weeks]
• Health-related quality of life (HRQoL) indicators of pregnant women [Срок оценки: 36 weeks]
• Health-related quality of life (HRQoL) indicators of pregnant women [Срок оценки: 36 weeks]

Критерии участия

Критерии включения

• Pregnant women aged between 20 and 40 years old
• Pregnancy duration between 20 to 28 weeks (screening for eligible patients can start from the 20th week of gestation)
• Clinically diagnosed with compensated chronic hepatitis B, HBsAg positive for more than 6 months, with clinical history, signs, and test results consistent with compensated chronic hepatitis B
• HBsAg and HBeAg positive in maternal serum during screening
• PCR testing shows maternal serum HBV DNA levels exceeding 200,000 IU/mL
• Subjects voluntarily agree to undergo treatment according to the study design's drug treatment plan and all other research requirements, and patients consent to strictly avoid pregnancy within 28 weeks postpartum
• Patients and their husbands (the biological parents of the child) understand the risks and voluntarily participate in the study. The mother must participate voluntarily and sign a written informed consent document before participating in the study.

Критерии исключения

• Creatinine clearance < 100 mL/min (calculated using the Cockcroft-Gault method based on serum creatinine and ideal body weight), or hypophosphatemia (below normal range).
• History of adverse renal reactions induced by Adefovir or history of Adefovir resistance.
• Meeting one of the following criteria: hemoglobin < 80 g/L, neutrophil count < 1000/μL, ALT > 5 times the upper limit of normal, total bilirubin > 20 mg/L, albumin < 25 g/L, abnormal levels of creatinine or urea nitrogen.
• Pregnant women with a history of miscarriage, history of giving birth to a child with congenital malformations, or history of fetal infection with hepatitis B virus.
• The biological father of the current pregnancy has chronic hepatitis B.
• The investigator assesses that the subject has significant kidney, cardiovascular, pulmonary, or neurological diseases that affect their participation in the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Китай · 10 центров

• Guangzhou Eighth People's Hospital, Guangzhou Medical University — Гуанчжоу
• Guangzhou Women and Children's Medical Center — Гуанчжоу
• The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou — Гуанчжоу
• The Third Affiliated Hospital of Guangzhou Medical University — Гуанчжоу
• Shenzhen Baoan Women's and Children's Hospital — Шэньчжэнь
• Shijiazhuang Maternity & Child Healthcare Hospital — Shijiazhuang
• The Fifth Hospital of Shijiazhuang — Shijiazhuang
• Xiangya Hospital, Central South University — Чанша
• … и ещё 2 центра

Идентификаторы

NCT: NCT06947356 · US-CN-P818

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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